The clock is ticking for the transition to ISO 13485:2016

The first year of the three-year transition period passed on 1 March 2017

The third edition of EN ISO 13485 - Medical devices — Quality management systems — Requirements for regulatory purposes – was published on 1 March 2016. This edition was a revision to ISO 13485:2003 and EN ISO 13485:2012. A three-year timeframe was set for transition of certification of a quality management system (QMS) to this new edition of EN ISO 13485:

  • New certificates to the previous edition of the standard will not be issued after 28 February 2018;
  • All certificates to the previous edition of the standard will expire on 28 February 2019.

Planning of the transition for your QMS should be complete and implementation of the changes should be underway. The first year of the three-year transition period has passed. There are only two years to go. If you have started the transition, you should check that you are still on track.

ISO 13485:2016 has additional detail regarding managing changes to a QMS. You will be expected to manage the changes to your QMS in accordance with the requirements of the standard. In particular, this means that:

  1. You have planned for the changes in accordance with the requirements for quality planning;
  2. You have records of these planning activities available as QMS records;
  3. Your plans have been reviewed in management review;
  4. You have allocated the financial and human resources needed.

You should already be in discussion with your Conformity Assessment Body to align on the transition process and timescale.

EN ISO 13485:2016 has 36 requirements indicating the regulatory requirements that have to be incorporated in your QMS. There are another 21 mentions of regulatory requirements outside of the requirements, in what are called informative elements of the standard. The forthcoming Regulations for medical devices and IVDs will require manufacturers to revise their QMS. These changes also need to be managed. Compliance with EN ISO 13485:2016 will be a step towards compliance with these Regulations as well.

If you have not yet started the transition, you need to begin as a matter of urgency if you don’t want to risk losing your certification to EN ISO 13485.


Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development.